qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00732-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-06-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Bio-rad have observed that the values for blood and ketones may gradually decrease, and values for ph may gradually increase over the shelf life of affected product lots. this issue is not expected to impact patient results.
  • 조치
    Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes. Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product.

Device

  • 모델명 / 제조번호(시리얼번호)
    qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD). Catalogue Numbers: 975, 975X, 995, 995X (12 mL), 962, 963, 964, 962X (120 mL)Lot Numbers: 78770, 78780, 80510, 80520, 80530, 80540, 80550, 80560, 79610, 79620, 79630, 79640, 79650, 79660ARTG Number: 206309Bio-Rad Laboratories - Clinical chemistry biological screening IVDs
  • Manufacturer

Manufacturer